Changes in Gene Expression and Prognosis of Blood Immune Cells After Cardiopulmonary Bypass Surgery

Acute Kidney Injury Clinical Trial

Official title:

Changes in Gene Expression and Prognosis of Blood Immune Cells After Cardiopulmonary Bypass Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05871203
• Other study ID #: 2023-0359
• Status: Recruiting
• Start date: May 17, 2023
• Est. completion date: July 10, 2023

Study information

• Verified date: May 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to learn about the changes in gene expression in blood immune cells in after cardiac surgery with cardiopulmonary bypass.The main question it aims to answer is: What specific gene expression changes predict kidney damage after cardiac surgery with cardiopulmonary bypass. Participants received conventional treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: July 10, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1) Age= 18 years old; 2) Cardiopulmonary bypass descending valve replacement (molding), or coronary artery bypass grafting, or macrovascular surgery.

Exclusion Criteria:

• 1) any cognitive or mental impairment that is unable to sign the informed consent form; 2) Have basic immune system and blood system diseases; 3) pregnancy; 4) Receiving radiotherapy and chemotherapy before surgery; 5) Receiving immunosuppressive drugs within six months; 6) Have participated in other interventional clinical trials within 30 days before surgery.

Exit Criteria:

1. Incomplete surgery;

2. Secondary transfer in the operating room;

3. Automatically request to terminate the test.

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Other:
• Gene sequencing
Participants were taken blood samples for gene sequencing at three time periods: before, after, and 24 hours after the end of the surgery

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Zhejiang University anesthesiology department	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative acute kidney injury	SCr was elevated = 26.5 micromol/L or 1.5 times the baseline for SCr = or urine output < 0.5 mL/kg/hour within 6 hours within 48 hours	Within 48 hours after surgery